MAUDE Adverse Event Report: DJO, LLC AIRCAST A60 ANKLE BRACE,L,RT; JOINT, ANKLE, EXTERNAL BRACE

Model Number 81-02TLR

Device Problem Collapse (1099)

Patient Problem Fall (1848)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that "metal stays poking through causing patient to fall and hurt her leg.The stays on the brace buckled while she was walking, causing her to fall." the patient was wearing the brace due to a fractured ankle.No further information is currently available.

• Brand Name: AIRCAST A60 ANKLE BRACE,L,RT
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c.
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9215111
• MDR Text Key: 208332868
• Report Number: 9616086-2019-00074
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 81-02TLR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2010
• Initial Date FDA Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1